CN102300540B - For improving the method for the against leakage performance comprised in the closed pressure charging system of septum sealed container - Google Patents
For improving the method for the against leakage performance comprised in the closed pressure charging system of septum sealed container Download PDFInfo
- Publication number
- CN102300540B CN102300540B CN200980155729.3A CN200980155729A CN102300540B CN 102300540 B CN102300540 B CN 102300540B CN 200980155729 A CN200980155729 A CN 200980155729A CN 102300540 B CN102300540 B CN 102300540B
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- Prior art keywords
- barrier film
- expose portion
- contact surface
- hard part
- pin
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Links
- 238000000034 method Methods 0.000 title claims abstract description 47
- 230000004888 barrier function Effects 0.000 claims abstract description 142
- 230000002093 peripheral effect Effects 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 7
- 230000006698 induction Effects 0.000 claims description 6
- 230000033001 locomotion Effects 0.000 claims description 6
- 238000011282 treatment Methods 0.000 claims description 6
- 230000007246 mechanism Effects 0.000 claims description 3
- 239000010408 film Substances 0.000 claims 16
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 230000002285 radioactive effect Effects 0.000 claims 1
- 239000010409 thin film Substances 0.000 claims 1
- 230000000144 pharmacologic effect Effects 0.000 description 9
- 238000004140 cleaning Methods 0.000 description 7
- 239000008187 granular material Substances 0.000 description 7
- 238000007789 sealing Methods 0.000 description 7
- 238000005452 bending Methods 0.000 description 5
- 239000003795 chemical substances by application Substances 0.000 description 4
- 239000003085 diluting agent Substances 0.000 description 4
- 239000012530 fluid Substances 0.000 description 4
- 238000003780 insertion Methods 0.000 description 4
- 230000037431 insertion Effects 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 239000002184 metal Substances 0.000 description 3
- 239000011859 microparticle Substances 0.000 description 3
- VIKNJXKGJWUCNN-XGXHKTLJSA-N norethisterone Chemical compound O=C1CC[C@@H]2[C@H]3CC[C@](C)([C@](CC4)(O)C#C)[C@@H]4[C@@H]3CCC2=C1 VIKNJXKGJWUCNN-XGXHKTLJSA-N 0.000 description 3
- 238000010010 raising Methods 0.000 description 3
- 230000005540 biological transmission Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 230000003993 interaction Effects 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000010399 physical interaction Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000005855 radiation Effects 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 238000012546 transfer Methods 0.000 description 2
- NIXOWILDQLNWCW-UHFFFAOYSA-M Acrylate Chemical compound [O-]C(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-M 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 230000009849 deactivation Effects 0.000 description 1
- 239000012895 dilution Substances 0.000 description 1
- 238000010790 dilution Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000004005 microsphere Substances 0.000 description 1
- 239000000941 radioactive substance Substances 0.000 description 1
- 239000011347 resin Substances 0.000 description 1
- 229920005989 resin Polymers 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1406—Septums, pierceable membranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D47/00—Closures with filling and discharging, or with discharging, devices
- B65D47/36—Closures with frangible parts adapted to be pierced, torn, or removed, to provide discharge openings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D90/00—Component parts, details or accessories for large containers
- B65D90/54—Gates or closures
Abstract
The present invention relates to a kind of method of the against leakage performance improved in closed pressure charging system.This method comprises: the closed system providing the container comprised with diaphragm seal, and described barrier film has the top surface of band expose portion, and described system is maintained at the direct draught at least about 5 pounds/square inch.The contact surface of hard part be placed to regularly with the marginal portion of the expose portion of barrier film or core at least partially or both are adjacent or contact, thus reduce the size of any projection or the distortion formed in the expose portion of barrier film.The invention still further relates to a kind of tool set for improving the against leakage performance in closed pressure charging system, this tool set comprises hard part.
Description
Technical field
The present invention relates to the method for the against leakage performance of raising pin-barrier film interface.More specifically, the invention provides the method improving the against leakage performance comprised in the closed system of septum sealed container, this closed system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch).
Background technology
Be used for preserving medicine, reagent or other pharmacy related substances and keep the vial of aseptic condition and other commercially available container usually with the diaphragm seal not being designed to resist high malleation.In order to transmit compound in this diaphragm seals container or goods, need goods to be poured or pushes container thus obtain the safe and efficient injection to patient or accepter.Two needle systems can with cleaning and the cleaning of helping septum sealed container; Pin pushes through flush fluid and goods and flush fluid are injected patient by transfer tube by second pin.Transfer tube from container to patient is generally the long duct with very little internal diameter.Long length and the combination of little diameter cause very large pressure reduction between the entrance and exit of conduit.Therefore, in sealed container, produce large counter-pressure, reason is that mobile fluid is by the suction force needed for conduit.Leakage in these type seal containers can cause the loss of goods integrity (release of the especially loss of bactericidal nature, danger or toxic material and the loss of enough active component for effectively treating).
Such as, water needs the pressure reduction of about 827.4kPa (120 pounds/square inch) with the 3French conduit that the flow velocity of about 1mL/sec flows through 1 meter long.3French conduit has the external diameter of 1mm and the internal diameter of about 0.6mm.The flow velocity of 1mL/sec or appropriateness, although the pressure (827.4kPa of this amplitude; 120 pounds/square inch) very large and diaphragm seal is not designed to stand this pressure usually.
Therefore, when to be difficult to from original container safety or effectively to draw back goods (as such as
y-90 glass microspheres or
when the treatment microdroplet of Y-90 resin microdroplet), need a kind of method improving the membrane properties of anti-this high pressure.Also there is other application wherein needing high against leakage performance, the mixing such as after material chemical reagent being added to diaphragm seals internal tank or cleaning.This application can comprise adds active component to original deactivation microdroplet, and it can comprise blend step and cleaning step successively.
Summary of the invention
The present invention relates to the method for the against leakage performance of raising pin-barrier film interface.More specifically, the invention provides the method improving the against leakage performance comprised in the closed system of septum sealed container, this closed system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch).
According to an aspect of the present invention, provide a kind of method for improving the against leakage performance in closed pressure charging system, described method comprises the steps:
There is provided the closed system of the container comprised with diaphragm seal, described barrier film has the top surface of band expose portion, and described system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch), and
The contact surface of hard part is placed to regularly with adjacent with lower part or with following part contact, to reduce the size of any projection or the distortion formed in the expose portion of barrier film:
I () is arranged on marginal portion in the expose portion of barrier film at least partially, adjacent and the contour along the expose portion of barrier film of the contour of the expose portion of described marginal portion and barrier film extends, described marginal portion has contour in the outer peripheral lines overlapped with the contour of the expose portion of barrier film and the expose portion being arranged on barrier film, and described interior contour and described outer peripheral lines limit the region of widened section; Or
(ii) core of the expose portion of barrier film at least partially, and described core extends to contour in marginal portion from the center of the expose portion of barrier film, and described core has the region limited by contour in marginal portion; Or
(iii) partly (i) and part (ii) both.
In the example of said method, the malleation kept in closed system is in the scope of (350 pounds/square inch) or any value between the two or subrange from about 34.5kPa (5 pounds/square inch) to about 2413kPa, from about 34.5kPa (5 pounds/square inch) to about 241.3kPa in the scope of (35 pounds/square inch) or any value between the two or subrange, or, from about 344.7kPa (50 pounds/square inch) to about 2413kPa in the scope of (350 pounds/square inch) or any value between the two or subrange.
In other example, the contact surface of hard part is substantially smooth or be substantially smooth circular surface.
The invention still further relates to the method for above restriction, wherein hard part has one or more than one passage, described one or more than one passage hold one or more than one pin, further, the contact surface of hard part has or the more than one opening that described or more than one pin extend through.By piercing through described expose portion with the end of each of described or more than one pin, the end of each of described or more than one pin can extend through one or more than one opening the expose portion being formed in described barrier film from described or the more than one opening of the contact surface of hard part.
In the further example of said method, described one or more than one opening on the contact surface of hard part both can be arranged in the core of contact surface, be disposed adjacent with the end of contact surface or contour, also can be openings of the core being arranged on contact surface.In addition, in the core that described or the more than one opening be formed in the expose portion of barrier film can be arranged on the expose portion of barrier film or with the end of the expose portion of barrier film or contour adjacent.
The gross area of described one or more than one opening on the contact surface of hard part can be less than the area of the expose portion of barrier film.In other example, the area of the contact surface of hard part is identical with the area of the contact surface of barrier film, the area of the contact surface that is less than barrier film or be greater than the area of contact surface of barrier film.
The solid components limited in said method can be included in one or more than one pin guiding tube in described one or more than one passage, described one or more than one pin guiding tube prevent the transverse movement of described or more than one pin, and bending in barrier film and strain subsequently.
The container limited in the method for above-mentioned restriction can comprise for injecting the mankind or animal patient or the goods for being transported to container; such as comprise the induction system of pharmacological activity goods, radioactivity goods or its mixture; or comprise pharmacological activity goods or radioactivity goods and the acceptable diluent of pharmacy or carrier; such as, the agent goods of granule (as comprising any size of pharmacological activity goods or radioactivity goods or the microparticle of shape or milli granule) or medical treatment device.Further, container may be used for mixing or cleaning.
In also further example, barrier film can be closed to container with fixture sealing member (such as metal or plastic clamp sealing member).
In further example, said method can also be included in defeats barrier film from using while septum sealed container transferring material.
According to another aspect, the present invention relates to a kind of tool set for improving the against leakage performance in closed pressure charging system, described closed system comprises the container of the diaphragm seal with the top surface with band expose portion, described system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch), and described tool set comprises:
There is the hard part of contact surface; With
For using described hard part to reduce the description of the size of any projection or the distortion be formed in the expose portion of barrier film.
The invention still further relates to the tool set of above-mentioned restriction, wherein said description describe the contact surface of described hard part is placed to regularly with adjacent with lower part or with following part contact:
I () is arranged on marginal portion in the expose portion of barrier film at least partially, adjacent and the contour along the expose portion of barrier film of the contour of the expose portion of described marginal portion and barrier film extends, described marginal portion has contour in the outer peripheral lines overlapped with the contour of the expose portion of barrier film and the expose portion being arranged on barrier film, and described interior contour and described outer peripheral lines limit the region of marginal portion; Or
(ii) core of the expose portion of barrier film at least partially, and described core extends to contour in marginal portion from the center of the expose portion of barrier film, and described core has the region limited by contour in marginal portion; Or
(iii) partly (i) and part (ii) both.
In the example of above-mentioned tool set, the malleation kept in closed system is in the scope of (350 pounds/square inch) or any value between the two or subrange from about 34.5kPa (5 pounds/square inch) to about 2413kPa, from about 34.5kPa (5 pounds/square inch) to about 241.3kPa in the scope of (35 pounds/square inch) or any value between the two or subrange, or, from about 344.7kPa (50 pounds/square inch) to about 2413kPa in the scope of (350 pounds/square inch) or any value between the two or subrange.
In other example, the contact surface of hard part is substantially smooth or be substantially smooth circular surface.
The invention still further relates to the tool set of above restriction, wherein hard part has one or more than one passage, described one or more than one passage hold one or more than one pin, further, the contact surface of hard part has or the more than one opening that described or more than one pin extend through.By piercing through described expose portion with the end of each of described or more than one pin, the end of each of described or more than one pin can extend through one or more than one opening the expose portion being formed in described barrier film from described or the more than one opening of the contact surface of hard part.
In the further example of above-mentioned tool set, described one or more than one opening on the contact surface of hard part both can be arranged in the core of contact surface, be disposed adjacent with the end of contact surface or contour, also can be openings of the core being arranged on contact surface.In addition, in the core that described or the more than one opening be formed in the expose portion of barrier film can be arranged on the expose portion of barrier film or with the end of the expose portion of barrier film or contour adjacent.
On the contact surface being included in the hard part in above-mentioned tool set, the gross area of described or more than one opening can be less than the area of the expose portion of barrier film.In other example, the area of the contact surface of hard part is identical with the area of the contact surface of barrier film, the area of the contact surface that is less than barrier film or be greater than the area of contact surface of barrier film.
The hard part limited in above-mentioned tool set can be included in one or more than one pin guiding tube in described one or more than one passage, described one or more than one pin guiding tube prevent the transverse movement of described or more than one pin, and bending in barrier film and strain subsequently.
The tool set of above-mentioned restriction can also comprise the container with diaphragm seal; wherein; container comprises for injecting the mankind or animal patient or the goods for being transported to another vessel; as comprised the induction system of pharmacological activity goods, radioactivity goods or its mixture; or comprise pharmacological activity goods or radioactivity goods and the acceptable diluent of pharmacy or carrier; such as, the agent goods of granule (as comprising any size of pharmacological activity goods or radioactivity goods or the microparticle of shape or milli granule) or medical treatment device.Further, container may be used for mixing or cleaning.
In also further example, barrier film can be closed to container with fixture sealing member (such as metal or plastic clamp sealing member).
Above-mentioned tool set also comprises for being remained on by hard part relative to the injector assembly in the fixed position of the expose portion of barrier film.
According to another aspect, the present invention relates to a kind of for improve against leakage performance in closed system, the use of the hard part with contact surface, the described closed container comprised with diaphragm seal, described barrier film has the top surface of band expose portion, described system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch), and wherein the contact surface of hard part is suitable for the size reducing any projection or the distortion formed in the expose portion of barrier film.
According to going back an aspect, the use of that the present invention relates to a kind of size of any projection or distortion for reducing the expose portion being formed in barrier film, that there is contact surface hard part, the expose portion of wherein said barrier film is arranged on the top surface of barrier film, diaphragm seal is to container, further, a part for the closed system of the direct draught remained at least about 34.5kPa (5 pounds/square inch) is formed with the container of diaphragm seal.
The invention still further relates to the use of above-mentioned restriction, wherein hard part contact surface be used for regularly be placed to adjacent with lower part or with following part contact:
I () is arranged on marginal portion in the expose portion of barrier film at least partially, adjacent and the contour along the expose portion of barrier film of the contour of the expose portion of described marginal portion and barrier film extends, described marginal portion has contour in the outer peripheral lines overlapped with the contour of the expose portion of barrier film and the expose portion being arranged on barrier film, and described interior contour and described outer peripheral lines limit the region of marginal portion; Or
(ii) core of the expose portion of barrier film at least partially, and described core extends to contour in marginal portion from the center of the expose portion of barrier film, and described core has the region limited by contour in marginal portion; Or
(iii) partly (i) and part (ii) both.
In the example of above-mentioned use, the malleation kept in closed system is from about 34.5kPa (in 5 pounds/square inch of scopes to about 2413kPa (350 pounds/square inch) or any value between the two or subrange, from about 34.5kPa (in 5 pounds/square inch of scopes to about 241.3kPa (35 pounds/square inch) or any value between the two or subrange, or, from about 344.7kPa (50 pounds/square inch) to about 2413kPa in the scope of (350 pounds/square inch) or any value between the two or subrange.
In other example, the contact surface of hard part is substantially smooth or be substantially smooth circular surface.
The invention still further relates to the use of above restriction, wherein hard part has one or more than one passage, described one or more than one passage hold one or more than one pin, further, the contact surface of hard part has or the more than one opening that described or more than one pin extend through.By piercing through described expose portion with the end of each of described or more than one pin, the end of each of described or more than one pin can extend through one or more than one opening the expose portion being formed in described barrier film from described or the more than one opening of the contact surface of hard part.
In the further example of the use of above-mentioned restriction, described one or more than one opening on the contact surface of hard part both can be arranged in the core of contact surface, be disposed adjacent with the end of contact surface or contour, also can be openings of the core being arranged on contact surface.In addition, in the core that described or the more than one opening be formed in the expose portion of barrier film can be arranged on the expose portion of barrier film or with the end of the expose portion of barrier film or contour adjacent.
The invention still further relates to the use of above restriction, on the contact surface of wherein hard part, the gross area of described or more than one opening can be less than the area of the expose portion of barrier film.In other example, the area of the contact surface of hard part is identical with the area of the contact surface of barrier film, the area of the contact surface that is less than barrier film or be greater than the area of contact surface of barrier film.
The hard part limited in above-mentioned use can be included in one or more than one pin guiding tube in described one or more than one passage, described one or more than one pin guiding tube prevent the transverse movement of described or more than one pin, and bending in barrier film and strain subsequently.
The invention still further relates to the use of above restriction; wherein container diaphragm seal; wherein container comprises for injecting the mankind or animal patient or the goods for being transported to another vessel; such as comprise the induction system of pharmacological activity goods, radioactivity goods or its mixture; or comprise pharmacological activity goods or radioactivity goods and the acceptable diluent of pharmacy or carrier; such as, the agent goods of granule (as comprising any size of pharmacological activity goods or radioactivity goods or the microparticle of shape or milli granule) or medical treatment device.Further, container may be used for mixing or cleaning.
In also further example, barrier film can be closed to container with fixture sealing member (such as metal or plastic clamp sealing member).
Accompanying drawing explanation
According to the description of hereinafter with reference accompanying drawing, these and other feature of the present invention will become obvious, in the accompanying drawings:
The bending effect that Fig. 1 display is caused by the pin that near-end is limited, far-end is the not limited insertion elastic diaphragm with sharp-pointed hypotenuse end (beveledend).
Fig. 2 display is according to the example of the method for reducing diaphragm deflection of the present invention, and it comprises the position of expose portion hard stand being placed on the barrier film of contiguous septum sealed container.
Fig. 3 display is according to the example of the method for reducing diaphragm deflection of the present invention, and it comprises stand to be placed to and contacts with the expose portion of the barrier film of septum sealed container.
Figure 4 and 5 display is according to the example of the method for reducing diaphragm deflection of the present invention, and it comprises hard stand and is placed to and contacts with the expose portion of the barrier film of septum sealed container and to apply external compressive force to stand.
Fig. 6 display is according to the plan view from above of the expose portion of the example of barrier film of the present invention.
Fig. 7 A-C shows the face upwarding view of the example of stand of the present invention.
Fig. 8 A-C shows the fragmentary top plan view of the example of the stand shown in Fig. 7 A-C, the expose portion contact of the barrier film that these stands are to that indicated in the drawings.The contact surface of stand is depicted as crosshatch to contribute to showing the contact area between each stand and the expose portion of barrier film.
Fig. 9 display comprises the transverse section plane graph of the example of the injector assembly according to stand of the present invention.
Figure 10-11 shows the transverse section plane graph of the injector assembly adjacent with the expose portion of the barrier film of diaphragm seal vial shown in Fig. 9.
Detailed description of the invention
The present invention relates to a kind of method improving pin-barrier film interface against leakage performance.More specifically, the invention provides a kind of method of the against leakage performance improved in closed system, this closed system comprises septum sealed container, and this closed system is maintained at the direct draught at least about 34.5kPa (5 pounds/square inch).
Septum sealed container normal first leak position is under stress in pin-barrier film interface.After sealing member barrier film being remained to container is curling, the against leakage performance (or compressive property) of septum sealed container can reasonably uprise moment, but As time goes on this value can reduce, reason is the creep (creep) (be for good and all out of shape under stress and relax) that most of elaxtic seal can produce naturally.Release-resistance loss of energy can accelerate by the contents of vial, due to the chemical interaction between goods and barrier film or physical interaction.When Y-90 microdroplet, produce physical interaction, reason is the radiation damage that the beta granule distributed from goods causes.Interaction material is determine damage ratio and creep subsequently or lax principal element relative to the position of barrier film.The against leakage performance of " lax " barrier film can be less than 34.5kPa (5 pounds/square inch).
During the Hi-pot test of septum sealed container, the barrier film observed under test is tending towards outwards " projection " (namely suffering serious distortion or high tension force), and reason is that As time goes on viewed internal pressure reduces the against leakage performance of barrier film.Fig. 1 shows the another kind of form of undesirable strain on barrier film 10, and it produces, in particular for those at the top pin be sharpened as having hypotenuse otch (bevelcut) 30 when pin 20a, 20b insert barrier film.When hypotenuse otch pin inserts barrier film 10, produced the hole of inclination by the initial openings of the top generation of fining away in the body of barrier film 10, if not laterally restriction ground insertion, then pin 20a, 20b can follow up.In the present invention, term " pin " refers to hollow pipe or sleeve pipe or syringe-like pin.In some cases, such as from septum sealed container flowing or transmission microdroplet, in order to optimal flow characteristic (that is, the quick flowing of microdroplet and transmission), importantly pin is located exactly.Under the certain situation of these situations, pin can be not limited and insert in the mode that the near-end of pin is limited at the far-end of pin with their transverse movement.These pins can bend to follow initial apertures direction.
At the end of the insertion of the pin that near-end is limited, far-end is not limited being with hypotenuse otch top, have two undesired effects.The first, pin bends and can not locate ideal position in a reservoir.The second, due to bending, barrier film suffers serious transverse strain, and this transverse strain is positioned at region 50 place that pin is inserted through barrier film.Limited at near-end, that far-end is not limited pin is used in the supercharging vial with convex diaphragms, this strain will increase.Therefore this local train may reduce the against leakage performance of pin-barrier film interface further significantly.
The invention provides the basic skills that three kinds of raisings comprise the against leakage performance of the closed system septation of septum sealed container and the interface of pin, as shown in Figure 2-5.Septum sealed container shown in Fig. 2-5 comprises vial 60, and barrier film 20 has been mounted to vial 60.Barrier film can be formed with container to seal and can by least one needle-penetration goods to be sent out any enclosed elastic device of container.Barrier film 10 keeps going up in place by crimping cap (crimpedcap) 70, the opening that crimping cap 70 has on its top, and this opening makes a part 80 for the top surface of barrier film 10 expose.In illustrated method, hard gantry components 90 by fixture or other type limiting element remain on regularly barrier film 10 expose portion 80 or near, with by any projection be formed in the expose portion 80 of barrier film 10 or distortion 100 size reduce to the projection 170 with relative small size.Gantry components 90 has for holding for dilution, a pair pin 20a rinsing and handle the contents of vial 60, the one or more passage (110 of 20b; 120a, 120b).Pin 20a, 20b are by making the hypotenuse terminal spine of pin wear barrier film and one or more opening (130 from the contact surface 150 being arranged on gantry components 90; 140a, 140b) extend through the pair of openings be formed in the expose portion of barrier film.
The motion of stand main body is subject to intensity and the hardness restriction of gantry components self, and is optionally subject to the restriction of outer retaining formation or device (such as fixture).In a word, in order to this object, can adopt obviously hard than barrier film and thickness is enough thick to such an extent as to by the projection extended from barrier film try hard to recommend dynamic time there is any material of insignificant distortion.
In the method shown in Fig. 2-4, gantry components 90 is remained on the fixed position of the expose portion 80 (Fig. 2) of contiguous barrier film 10 or directly remains on the expose portion 80 of barrier film 10 by outer hardened mechanism or rigid structure, thus any projection making at least in part to be formed on the expose portion 80 of barrier film 10 or distortion 100 flatten.In the method shown in Fig. 4-5, while septum sealed container transferring material, on stand, also apply external pressure 180 in downward direction, thus keep the pressure to barrier film.Can adopt any conventional method applying this power, such as injector assembly, next it will be described in more detail.
Being deflected by pin when inserting to reduce and to bend the barrier film distortion caused, rigid needle guiding piece 190a, 190b can place near barrier film 10 very much, make the initial apertures produced in barrier film suitably align (see Fig. 5) with direction of insertion.Pin guiding piece 190a, 190b are also used as keep pin suitably straight and align with the ideal position for optimal fluid flow dynamic characteristic.Optionally, pin guiding piece can have enlarging near-end 200, pin 20a, 20b is inserted the passage 120a of gantry components 90,120b to facilitate at the assembly process of system.For the method for all framves of setting up the stage, one or more than one opening (130 in the stand main body 90 of restriction barrier film distortion; 140a, 140b) region be less than the region of the expose portion 80 of barrier film 10 ideally.In addition, the diameter being allowed to protruding part reducing barrier film reduces the distortion under setting pressure, and therefore improves against leakage performance.Further, the contact surface of stand is arranged the enough large effect that will maximize stand with the opening allowing pin to insert just.
In the example shown in Fig. 2-4, the expose portion 80 of barrier film 10 has two independently subdivisions: (i) is arranged on the marginal portion 210 in the expose portion of barrier film, and the contour 230 of expose portion of its contiguous barrier film the contour 230 along the expose portion of barrier film extend; With, (ii) extends to the core 220 (Fig. 6) of contour 240 in widened section from the center of the expose portion of barrier film.Marginal portion 210 has contour 240 in the outer peripheral lines overlapped with the contour 230 of the expose portion of barrier film and the expose portion being arranged on barrier film, and interior contour and outer peripheral lines limit the region of marginal portion.The region of core 210 is limited by contour in marginal portion 240.
Gantry components 90 shown in Fig. 2-4 has the opening 110 (Fig. 7 A) that the single center be present in contact surface 150 is arranged.Fig. 8 A shows in cross-hatched mode the region that the region overlapped between the expose portion 80 (Fig. 6) of the gantry components 90 shown in Fig. 7 A and barrier film 10 is defined as the marginal portion 210 of the expose portion 80 of barrier film.As a result, the outside of the expose portion protrusions or distortion that are formed in barrier film only flattens when contacting with the contact surface 150 of the stand shown in Fig. 7 A.
Fig. 7 C shows the replaceable example of stand, the core 220 of the size of this stand and the expose portion 80 of barrier film 10 roughly equal.Fig. 8 C shows in cross-hatched mode the region that the region overlapped between the expose portion 80 (Fig. 6) of the gantry components 90 shown in Fig. 7 C and barrier film 10 is defined as the core 220 of the expose portion 80 of barrier film.As a result, the core being only formed in projection in the expose portion of barrier film or distortion only flattens when contacting with the contact surface 150 of the stand shown in Fig. 7 C.
As a result, although according to of the present invention, use the method for the stand shown in Fig. 2-4,7A and 7C can reduce the overall dimension of the projection be formed in the expose portion of barrier film, they can not eliminate projection completely.
In the example depicted in fig. 5, two independently center opening 140a is set, 140b is present in (Fig. 7 B) on the contact surface 150 of gantry components 90, like this, the contact surface 150 of gantry components contacts (Fig. 8 B) with most of regions of core 220 with all regions of the marginal portion 210 of the expose portion 80 of barrier film 10.As a result, this example of method of the present invention can be eliminated in mode completely and be formed in any projection in the expose portion of barrier film or distortion.
The degree of required barrier film strain adjusted is required pressure, membrane configuration and based on resting period and the function of slack that produces with the interactional degree of comprised goods.The most effective strain adjusted (in use external force compression barrier film) allows to use the pressure to 2413kPa (350 pounds/square inch).For not standing too large pressure (such as, < 34.5kPa (5 pounds/square inch)) completely lax barrier film, against leakage performance can be brought up to about 2413kPa (350 pounds/square inch) from < 34.5kPa (5 pounds/square inch) by aforementioned strain adjusted method (stand in conjunction with pin guiding piece), and the method used depends on pressure demand.
See Fig. 9, show the example of injector assembly 250, injector assembly 250 comprises the plunger mechanism be connected with the stand shown in Fig. 5, and it comprises the plunger 260 be positioned at slidably in plunger bushing 270.Plunger bushing has the extend longitudinally interior compartment for holding pin 20a and 20b, and pin 20a and 20b is fixed on the centre position of the inside of plunger 260.Pin 20a is connected to diluent source, the acceptable saline solution of such as pharmacy or buffer agent, and the conduit that pin 20b is connected to accepted downstream vial or is connected to for inserting in patient.Before use, plunger is positioned at retracted position, and the lower end of pin 20a and 20b is closed in plunger bushing 270 that the top of passage is closed in stand 90, and the contact surface of stand 90 is coated with cap 290 to prevent the bench surface of aseptic condition contaminated.
In order to assemble according to induction system of the present invention, the gantry components 90 that diaphragm seal vial 60 is placed on injector assembly 250 is transferred, and aligns with the center of the expose portion of barrier film 10 in the center of the contact surface of stand 90.Top to the handle 265 of injector assembly 250 applies pressure and causes the end of pin 20a and 20b along extending through the opening in the contact surface of stand 90 in downward direction and piercing through barrier film 10 and enter vial 60 (Figure 10).The restriction stretching into the Contact being subject to the distal portions 275 of plunger 260 and the top surface 285 of stand 90 further of pin.Injector assembly optionally can comprise brake, such as plastic button is taken or spherical plunger detents, engage with the maintenance edge be arranged in plunger bushing 270 or hole while it is arranged on the top surface 285 engaging stand 90 on plunger 260 and at the distal portions 275 of plunger 260, thus prevent the retraction of plunger 260.
The vial comprising interested compound and composition can be arranged on the vial keeper 310 interior (Figure 11) of the top boring had for holding stand 90.If vial comprises radioactive substance, the protectiveness material of any radiation that so vial keeper can be launched with attenuating material is made, as being made up of acrylate or lead.Vial keeper also comprises the collar 300, to help plunger bushing 270 and stand 90 to align with the top of vial 60.In the process of assembling induction system, when the distal portions of stand and plunger bushing moves in vial keeper, the holddown spring ring 305 be arranged on the bottom of stand 90 is received in the groove (not shown) in the inner radial surface on the top being arranged on this collar, to form compression fit (compressionfit) between the end and stand 90 of the collar, plunger bushing, stand remains in vial keeper by regularly.
Eight months periods relating to 1301 patient treatments of carrying out using the method for the against leakage performance in the closed pressure charging system for improving the direct draught be maintained between 5 pounds/square inch and 35 pounds/square inch of the present invention, do not hear the leakage of the adjacent component of barrier film and system.
It is to be appreciated that the present invention's embodiment disclosed herein is that principle of the present invention is described.Other amendment that can adopt within the scope of the invention.Therefore, for example, and nonrestrictive, interchangeable structure of the present invention can be adopted according to teaching here.Therefore, the present invention is not limited to just in time shown and described those.
Claims (13)
1., for improving a method for the against leakage performance in closed pressure charging system, described method comprises the steps:
There is provided the closed system of the container comprised with diaphragm seal, described barrier film has the top surface of band expose portion, and described system is maintained at the direct draught of at least 34.5kPa (5 pounds/square inch), and
The contact surface of hard part is placed to and following part contact regularly, to reduce the size of any projection or the distortion formed in the expose portion of barrier film:
I () is arranged on marginal portion in the expose portion of barrier film at least partially, adjacent and the contour along the expose portion of barrier film of the contour of the expose portion of described marginal portion and barrier film extends, described marginal portion has contour in the outer peripheral lines overlapped with the contour of the expose portion of barrier film and the expose portion being arranged on barrier film, and described interior contour and described outer peripheral lines limit the region of marginal portion; With
(ii) core of the expose portion of barrier film is at least partially, and described core extends to contour in marginal portion from the center of the expose portion of barrier film, and described core has the region limited by contour in marginal portion,
Wherein said hard part than described thin film hard and thickness is enough thick thus by the projection extended from barrier film try hard to recommend dynamic time there is insignificant distortion.
2. the method for claim 1, the malleation kept in wherein said closed system is from 34.5kPa (5 pounds/square inch) in the scope of 2413kPa (350 pounds/square inch).
3. the method for claim 1, wherein said hard part has one or more than one passage, described one or more than one passage hold one or more than one pin, further, the contact surface of described hard part has or the more than one opening that described or more than one pin extend through.
4. method as claimed in claim 3, the end of each of wherein said or more than one pin extends through one or more than one opening the expose portion being formed in described barrier film from described one or the more than one opening of the contact surface of described hard part.
5. method as claimed in claim 4, wherein said hard part is included in one or more than one pin guiding tube in described one or more than one passage, and described one or more than one pin guiding tube prevent the transverse movement of described or more than one pin.
6. the method for claim 1, wherein said container comprises for injecting the mankind or animal patient or the goods for being transported to container.
7. method as claimed in claim 6, wherein said goods are the medical treatment device or the induction system that comprise active pharmaceutical ingredient, radioactive composition or its mixture.
8. the method for claim 1, is also included in and defeats barrier film from using while septum sealed container transferring material.
9. the method for claim 1, is placed to the contact surface of described hard part with the adjacent at least partially of the core of the expose portion of described barrier film regularly or contacts.
10. the method for claim 1, is placed to the contact surface of described hard part adjacent with the described core of the expose portion of described barrier film regularly or contacts.
11. the method for claim 1, the contact surface of described hard part is placed to regularly with the described marginal portion of the expose portion of described barrier film at least partially and the contacting at least partially of described core.
12. the method for claim 1, are placed to the contact surface of described hard part regularly and contact with described core with the described marginal portion of the expose portion of described barrier film.
13. methods according to any one of claim 1-12, use outer hardened mechanism or rigid structure to keep the contact surface of described hard part regularly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510691099.9A CN105395363B (en) | 2009-01-30 | 2009-12-08 | Method for improving the release-resistance energy in the closing pressure charging system for including septum sealed container |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US14853409P | 2009-01-30 | 2009-01-30 | |
| US61/148,534 | 2009-01-30 | ||
| PCT/CA2009/001770 WO2010085870A1 (en) | 2009-01-30 | 2009-12-08 | Method for increasing the leakage resistance in a closed, pressurized system comprising a septum-sealed container |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510691099.9A Division CN105395363B (en) | 2009-01-30 | 2009-12-08 | Method for improving the release-resistance energy in the closing pressure charging system for including septum sealed container |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102300540A CN102300540A (en) | 2011-12-28 |
| CN102300540B true CN102300540B (en) | 2015-11-25 |
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|---|---|---|---|
| CN201510691099.9A Active CN105395363B (en) | 2009-01-30 | 2009-12-08 | Method for improving the release-resistance energy in the closing pressure charging system for including septum sealed container |
| CN200980155729.3A Active CN102300540B (en) | 2009-01-30 | 2009-12-08 | For improving the method for the against leakage performance comprised in the closed pressure charging system of septum sealed container |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510691099.9A Active CN105395363B (en) | 2009-01-30 | 2009-12-08 | Method for improving the release-resistance energy in the closing pressure charging system for including septum sealed container |
Country Status (12)
| Country | Link |
|---|---|
| US (2) | US9402784B2 (en) |
| EP (1) | EP2391329B1 (en) |
| JP (1) | JP5917152B2 (en) |
| KR (1) | KR101721056B1 (en) |
| CN (2) | CN105395363B (en) |
| BR (1) | BRPI0925287A8 (en) |
| CA (1) | CA2749868C (en) |
| ES (1) | ES2640936T3 (en) |
| PT (1) | PT2391329T (en) |
| RU (1) | RU2484808C2 (en) |
| WO (1) | WO2010085870A1 (en) |
| ZA (1) | ZA201104846B (en) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP5917152B2 (en) * | 2009-01-30 | 2016-05-11 | バイオコンパティブルス・ユーケー・リミテッド | Method for enhancing leakage resistance of a pressurized closed system with a bulkhead sealed container |
| JP2014504921A (en) * | 2010-12-30 | 2014-02-27 | ジーイー・ヘルスケア・リミテッド | Multi-vial dispensing |
| EP2680807B1 (en) * | 2011-03-04 | 2016-08-10 | Duoject Medical Systems Inc. | Easy linking transfer system |
| EP2773309B1 (en) * | 2011-10-31 | 2016-04-20 | GE Healthcare Limited | Pierce and fill device |
| US9724269B2 (en) | 2012-11-30 | 2017-08-08 | Becton Dickinson and Company Ltd. | Connector for fluid communication |
| US10022301B2 (en) | 2013-03-15 | 2018-07-17 | Becton Dickinson and Company Ltd. | Connection system for medical device components |
| US10370156B2 (en) * | 2014-08-07 | 2019-08-06 | Becton, Dickinson And Company | One-piece safety tube closure with film element |
| WO2018024092A1 (en) * | 2016-08-03 | 2018-02-08 | 山东新华安得医疗用品有限公司 | Closed fluid transfer device and closed fluid transfer method |
| DE102017002401A1 (en) * | 2017-03-07 | 2018-09-13 | Kocher-Plastik Maschinenbau Gmbh | Plastic container product |
| DE102018130325A1 (en) | 2018-11-29 | 2020-06-04 | Heuft Systemtechnik Gmbh | Leak detection |
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- 2009-12-08 ES ES09839055.2T patent/ES2640936T3/en active Active
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- 2009-12-08 RU RU2011126889/15A patent/RU2484808C2/en not_active IP Right Cessation
- 2009-12-08 CA CA2749868A patent/CA2749868C/en active Active
- 2009-12-08 PT PT98390552T patent/PT2391329T/en unknown
- 2009-12-08 US US13/147,162 patent/US9402784B2/en active Active
- 2009-12-08 KR KR1020117020135A patent/KR101721056B1/en active IP Right Grant
- 2009-12-08 CN CN200980155729.3A patent/CN102300540B/en active Active
- 2009-12-08 BR BRPI0925287A patent/BRPI0925287A8/en not_active Application Discontinuation
- 2009-12-08 EP EP09839055.2A patent/EP2391329B1/en active Active
- 2009-12-08 WO PCT/CA2009/001770 patent/WO2010085870A1/en active Application Filing
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Also Published As
| Publication number | Publication date |
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| US9974710B2 (en) | 2018-05-22 |
| CA2749868C (en) | 2017-03-28 |
| ES2640936T3 (en) | 2017-11-07 |
| CN102300540A (en) | 2011-12-28 |
| KR101721056B1 (en) | 2017-03-29 |
| KR20110116193A (en) | 2011-10-25 |
| RU2484808C2 (en) | 2013-06-20 |
| BRPI0925287A2 (en) | 2016-07-26 |
| PT2391329T (en) | 2017-10-06 |
| EP2391329A1 (en) | 2011-12-07 |
| WO2010085870A1 (en) | 2010-08-05 |
| CA2749868A1 (en) | 2010-08-05 |
| BRPI0925287A8 (en) | 2017-12-05 |
| US20120053554A1 (en) | 2012-03-01 |
| JP5917152B2 (en) | 2016-05-11 |
| EP2391329A4 (en) | 2014-11-19 |
| ZA201104846B (en) | 2012-10-31 |
| RU2011126889A (en) | 2013-03-10 |
| US9402784B2 (en) | 2016-08-02 |
| CN105395363A (en) | 2016-03-16 |
| EP2391329B1 (en) | 2017-06-28 |
| CN105395363B (en) | 2019-03-08 |
| JP2012516165A (en) | 2012-07-19 |
| US20170079881A1 (en) | 2017-03-23 |
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